Food-effect Study on Uracil and Dihydrouracil Levels as a Diagnostic Marker of Dihydropyrimidine Dehydrogenase Activity
Not Applicable
Completed
- Conditions
- Drug Safety Biomarkers
- Registration Number
- NCT02718664
- Lead Sponsor
- The Netherlands Cancer Institute
- Brief Summary
Healthy volunteer food-effect study to determine the effect of food on uracil and dihydrouracil levels in plasma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
- Healthy volunteer; not known with cancer or current treatment for cancer
- Age at least 18 years
- Able and willing to give written informed consent
- Able and willing to consume the prescribed breakfast
- Able and willing to undergo blood sampling
Exclusion Criteria
- Any treatment with investigational drugs within 30 days before the start of the study
- Any condition that may interfere with the study protocol
- Women who are pregnant
- Allergies or intolerance for components of the prescribed breakfast
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Uracil levels (ng/ml) and dihydrouracil levels (ng/ml), compared in fed and fasting condition 2 test days 12 blood samples taken on both test days (fed and fasting condition), to investigate the effect of food on uracil and dihydrouracil levels
- Secondary Outcome Measures
Name Time Method dihydropyrimidine dehydrogenase enzyme activity (nmol/mg*h) baseline Dihydropyrimidine dehydrogenase enzyme activity is assessed at baseline to rule out any potential influence of dihydropyrimidine dehydrogenase deficiency on uracil and dihydrouracil levels
Trial Locations
- Locations (1)
The Netherlands Cancer Institute
🇳🇱Amsterdam, Netherlands
The Netherlands Cancer Institute🇳🇱Amsterdam, Netherlands